眼用制剂变更标准后的检查技术要求研究  

Research on inspection technology for ophthalmic preparations after quality standard modification

作　　者：宋飞[1] 赵红菊 赵双春 魏晶[1,2] 

机构地区：[1]沈阳药科大学工商管理学院,沈阳110016 [2]辽宁省药品认证中心,沈阳110003

出　　处：《中国新药杂志》2016年第21期2421-2425,共5页Chinese Journal of New Drugs

摘　　要：在眼用制剂生产企业GMP检查收官之际,梳理眼用制剂检查已有经验,并结合我国眼用制剂制药行业背景,初步总结眼用制剂在变更标准后现场检查的重点及风险关注点,为药品相关检查给予指导,供相关制药企业借鉴。At the end of GMP inspections for ophthalmic preparations,inspection experiences were summarized in this article,and the key point and the main risk points of the spot inspection after the quality standard modification were analyzed,taking the status of the ophthalmic preparations production enterprises in our country into consideration,aiming to give a guidance to carry out inspection actions in the next step,and provide information for the relevant pharmaceutical companies.

关 键 词：眼用制剂 GMP检查 变更研究 

分 类 号：R95[医药卫生—药学]